WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) is continuing to crack down on the illegal sale of unauthorized e-cigarettes, issuing complaints for civil money penalties (CMPs) against 21 retailers.
The FDA previously sent each of these retailers a warning letter based on their sale of unauthorized Esco Bars, a popular youth-appealing brand. During follow-up inspections, the FDA observed that the retailers had not corrected the violations, which resulted in these CMP actions.
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"These retailers were duly warned of what could happen if they continued selling these unauthorized e-cigarettes," said Brian King, Ph.D., M.P.H., director of the FDA's Center for Tobacco Products. "They should have acted responsibly to correct the violations, but they chose not to do so and now must face the consequences of that decision. FDA won't sit back and tolerate inaction to comply with the law."
The complaints represent the first set of CMPs the FDA has filed for the sale of unauthorized Esco Bars e-cigarettes. The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. The penalty is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products in September, November and December.
The retailers can opt to pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. If they do not take action within 30 days of receiving the complaint, they risk a default order imposing the full penalty amount.
According to the 2023 National Youth Tobacco Survey, Esco Bars were the second most commonly used brand among youth e-cigarette users; among middle and high school students who reported using e-cigarettes in the past 30 days, about one in five said they used Esco Bars products during that period.
The recent CMP actions are just the latest in the continued, comprehensive push by the FDA to take action across the supply chain to remove unauthorized e-cigarettes, particularly those that are popular among youth, from the marketplace, the agency said.
As of Jan. 30, the FDA issued more than 440 warning letters and 88 CMPs to retailers, including brick and mortar and online retailers, for selling unauthorized tobacco products. In addition to actions involving retailers, the FDA has issued more than 660 warning letters to firms for illegally manufacturing and/or distributing unauthorized new tobacco products, including e-cigarettes.
[Read more: FDA Fines Retailers Over Illegal Sale of Youth-Appealing Vapor Products]
The agency has also filed civil money penalty complaints against 48 e-cigarette firms for manufacturing unauthorized products and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully marketed and sold in the United States. When e-cigarettes lack a marketing authorization order from the FDA, selling or distributing them to consumers in the U.S. is prohibited under the Federal Food, Drug, and Cosmetic Act.